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2023-506138-65-00CompletedPhase 4

Impact of trimetazidine on endothelial function and biomarkers correlating with the prognosis of heart failure with preserved ejection fraction

Source: EU CTIS (euclinicaltrials.eu) · Last updated 25 May 2025

Next steps

Brief summary (registry, in English)

Assessment of the number of events resulting from heart failure exacerbation or cardiovascular death.

Status (registry)
Completed
Phase (registry)
Phase 4
Study type
Interventional
Enrollment
468 (actual)
First submitted
4 Sept 2023
Start date
20 Feb 2025
Lead sponsor
Medical University Of Gdansk
EU CT number
2023-506138-65-00

What you commit to

  • Study type: Interventional · Phase 4
  • Participants enrolled: 468
  • 12 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.

Who cannot take part

Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.

Lab values

  • Current treatment in another clinical trial. 2. Hypersensitivity to trimetazidine. 3. Symptoms of parkinsonism. 4. Unavailability for all visits. 5. ≥3 class in CCS scale 6. Revascularization or venous thromboembolism within 3 months prior to the screening visit. 7. Hemodynamically significant valvular disease, hypertrophic cardiomyopathy, myocarditis and pericarditis, congenital heart disease, cardiac amyloidosis. 8. Severe ventricular arrhythmias. 9. Uncontrolled BP: SBP >170 or <85 mmHg or DBP >100 mmHg at screening or randomization visit; 10. Resting heart rate (HR) >110/min or <50/min; 11. Chronic kidney disease with eGFR <30 mL/min. 12. Blood total bilirubin ≥2 times the upper limit of normal (ULN) or ALAT or AST ≥3 times the (ULN). 13. Patient life expectancy <2 years. 14. Diagnosed malignant neoplasm within 5 years prior to screening or active cancer disease. 15. Organ transplant recipient. 16. Alcoholism. 17. Active infection as assessed by the investigator 18. Severe dysfunction of the musculoskeletal system. 19. Blood concentration of TSH or fT4 exceeding by 50% the upper and/or lower limit of the reference range. 20. Taking any drugs related to the treatment of Parkinson's disease, i.e. levodopa, dopamine agonists, anticholinergics, MAO-B inhibitors, COMT inhibitors, amantadine within three months before screening. 21. A woman trying to get pregnant naturally or in vitro, or a woman who is menstruating unwilling to protect herself against unplanned pregnancy.

Who the study is looking for

  • Expressing willingness to participate in the study and after obtaining information about the study, signing the informed consent form for participation in the clinical study. 2. Age at study entry ≥55 years and ≤85 years; 3. NYHA Class I to III at last screening assessment. 4. Documented diagnosis of HFpEF or new diagnosis of HFpEF based on HFA-PEFF score ≥ 5 by a cardiologist during the screening phase. 5. LVEF ≥ 50% on echocardiographic screening. 6. No modification of pharmacotherapy for at least 3 months prior to screening

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on EU CTIS (euclinicaltrials.eu)

Sites (12)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Szpital Uniwersytecki Nr 1 Im. Dr. A. Jurasza W BydgoszczyBydgoszczPolandCompleted
KARDIOLAB Poradnia KardiologicznaElblągPolandCompleted
Uniwersyteckie Centrum KliniczneGdanskPolandCompleted
Copernicus Podmiot Leczniczy Sp. z o.oGdanskPolandCompleted
Uniwersyteckie Centrum Medycyny Morskiej i TropikalnejGdyniaPolandCompleted
NZOZ Centrum Medyczne Dąbrowa-DąbrówkaGdyniaPolandCompleted
Salve Medica Sp. z o.o. S.K.LodzPolandCompleted
Specjalistyczna Praktyka Lekarska — "NEFRON" Beata Januszko-GiergielewiczOlsztynPolandCompleted
Wojewódzki Szpital Specjalistyczny im. Janusza Korczaka w Słupsku Sp. z o.o.SłupskPolandCompleted
Narodowy Instytut Geriatrii Reumatologii I Rehabilitacji Im Prof. Dr Hab. Med. Eleonory ReicherWarsawPolandCompleted
Państwowy Instytut Medyczny Ministerstwa Spraw Wewnętrznych i AdministracjiWarszawaPolandCompleted
Praktyka Lekarska - Tomasz BorkowskiWłocławekPolandCompleted

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